Romanian Society of Pharmaceutical Sciences

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CORRELATIONS IN SILICO/IN VITRO/IN VIVO REGARDING DETERMINATING ACUTE TOXICITY IN NON-CLINICAL EXPERIMENTAL TRIAL, ACCORDING TO BIOETHIC REGULATIONS INFORCED BY THE EUROPEAN UNION

SIMONA NEGREŞ 1#, MIHAELA DINU 2#, ROBERT VIOREL ANCUCEANU2*, TUDOREL OCTAVIAN OLARU2, MIHAELA VIOLETA GHICA3, OANA CRISTINA ŞEREMET1, CRISTINA ELENA ZBÂRCEA1, BRUNO ŞTEFAN VELESCU1, EMIL ŞTEFĂNESCU1, CORNEL CHIRIŢĂ1

“Carol Davila” University of Medicine and Pharmacy Bucharest, Faculty of Pharmacy, 6 Traian Vuia Street, 020956, Bucharest, Romania
1.Department of Pharmacology and Clinical Pharmacy
2.Department of Pharmaceutical Botany
3.Department of Physical and Colloidal Chemistry

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A non-clinical experimental trial on laboratory animals was conducted in order to determine the acute toxicity of 7 newly synthesized compounds (derivatives of beta phenyl-ethyl-amine) with potential antidiabetic/antiobesity effect. The trial objective was to reduce to minimum, according to European regulations, the number of laboratory animals employed in order to determine the lethal dose 50% (DL50). To this end, alternative methods of toxicity evaluation were used: in silico (QSAR method) and in vitro (plant cell inhibition), which were applied in consecutively performed in vivo trial (white male mice, NMRI strain). The research established a good correlation between the performed tests and may serve as a screening model for active substances with high biological potential.